Eliminate regulatory remediation results - FDA 483s or Warning Letters - Achieve a compliant, effective & efficient Quality Management System - diagnose, develop, implement, validate and quantify critical business process effectiveness. Getting new product into market quickly and effectively is the key to success.
Developing product consistent with FDA requirements while not slowing the R&D effort is a tricky business; if the system is designed properly, you can have both. Ever wonder why companies face recurring problems, missing deadlines & targets - costing time & money?
Developing product consistent with FDA requirements while not slowing the R&D effort is a tricky business; if the system is designed properly, you can have both. Ever wonder why companies face recurring problems, missing deadlines & targets - costing time & money?
Services
Solved a quality/regulatory problem by implementing a new sterile packaging system at a multinational client under FDA warning letter situation. Process validations for extrusion, injection molding, manufacturing & packaging equipment and sterilization. Conducted rapid corrective actions to bring molding operations into regulatory compliance.
JD Consulting works closely with its clients and their manufacturing team. Based on our many years of experience, we have developed methodologies and a process that eases the transition. We work collaboratively with your team from the initial analysis to implementation of final resolution. Your staff will be left empowered, with a deeper understanding so that they can produce excellent results while moving through the process development.
ISO 13485/CE/QSR compliance includes design control, FMEA, audits, validations and effective solutions to regulatory problems. 510(k) submissions and timely approvals implemented quality programs that pass FDA and ISO audits. Saved hundreds of thousands of dollars by innovative problem solving to reduce waste and increase productivity.
We won't propose more work than is necessary and are committed to charging a fair fee to complete the job. Because our clients place their trust in us to guide them through complicated regulatory processes, JD Consulting always represents their best interests and ensures that all company objectives and regulations are consistently met.
Jack assisted SSL and our joint venture partners, TTK-LIG, in the preparation for and during an FDA inspection of our factory and R&D facilities in India that make medical devices (Durex male condoms). Jack's professional and courteous assistance was of great help to us during this process and afterwards when we were responding to the small number of relatively minor 483 citations.
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